R01AG078153

Physical Rehabilitation for Older Patients with Acute HFPEF - The Rehab-HFPEF Trial

Acute decompensated heart failure (ADHF) is the leading cause of hospitalization in older persons and is associated with marked physical disability, poor health-related quality of life (HRQOL), frequent rehospitalizations, loss of independence, high mortality, and enormous healthcare costs. However, most of the trials testing a wide range of medications and strategies in ADHF have been neutral.

In our recently completed NIA-funded Phase 2 trial (REHAB-HF), an innovative, early, transitional, tailored, and progressive multi-domain physical rehabilitation intervention produced a large improvement in the primary outcome of short physical performance battery (+1.5 points) in older patients with ADHF.

At baseline, the participants (53%) with heart failure with preserved ejection fraction (HFPEF) had significantly worse impairments in physical function, frailty, HRQOL, and depression than those with heart failure with reduced EF. They also appeared to derive greater benefit from the intervention, with approximately 50% larger effect sizes in physical function, frailty, HRQOL, and depression.

Patients with HFPEF also appeared to have much greater reductions in rehospitalizations and death and potential for reduced medical resource use. The finding of potentially greater benefit in HFPEF is noteworthy as HFPEF is highly relevant to older persons and has the most urgent need for new treatments since it is:

1) The most common form of heart failure, nearly unique to older persons, and disproportionately affects older women and black persons;
2) Increasing in prevalence;
3) Accepted as a geriatric syndrome;
4) Associated with marked impairments in physical function and HRQOL and high rates of frailty;
5) Has high morbidity and mortality which are worsening over time;
6) Has limited evidence-based treatments.

The Phase 3 Rehab-HFPEF trial will focus on this large, growing, vulnerable, underserved population. The 5-year, randomized, attention-controlled, single-blinded trial will enroll 880 older adults aged >60 years with ADHF and HFPEF across 20 geographically dispersed clinical centers.

We will test the hypothesis that the innovative Rehab-HF intervention will improve the clinically compelling combined primary endpoint of all-cause rehospitalizations and mortality during 6-month follow-up, the most vulnerable time period following ADHF hospitalization (AIM 1), and the secondary endpoint of prevalence of major mobility disability, a clinically meaningful outcome in trials of older adults, at 6 months (AIM 2). We will also assess the intervention's impact on HRQOL, frailty, depression, physical activity, and healthcare costs.

Our diverse, cohesive, multi-disciplinary team and experience from the Phase 2 trial will ensure efficient and effective execution and dissemination. Rehab-HFPEF directly addresses the key recommendations of several recent NIA and NHLBI sponsored workshops. Its results could improve key outcomes that are meaningful to patients, caregivers, health systems, and payers.

The trial has strong potential to change clinical guidelines, reduce healthcare costs, and influence national coverage decisions for the large, growing, underserved, high-risk population of older patients with acute HFPEF.

Wake Forest University Health Sciences

TO ENCOURAGE BIOMEDICAL, SOCIAL, AND BEHAVIORAL RESEARCH AND RESEARCH TRAINING DIRECTED TOWARD GREATER UNDERSTANDING OF THE AGING PROCESS AND THE DISEASES, SPECIAL PROBLEMS, AND NEEDS OF PEOPLE AS THEY AGE. THE NATIONAL INSTITUTE ON AGING HAS ESTABLISHED PROGRAMS TO PURSUE THESE GOALS. THE DIVISION OF AGING BIOLOGY EMPHASIZES UNDERSTANDING THE BASIC BIOLOGICAL PROCESSES OF AGING. THE DIVISION OF GERIATRICS AND CLINICAL GERONTOLOGY SUPPORTS RESEARCH TO IMPROVE THE ABILITIES OF HEALTH CARE PRACTITIONERS TO RESPOND TO THE DISEASES AND OTHER CLINICAL PROBLEMS OF OLDER PEOPLE. THE DIVISION OF BEHAVIORAL AND SOCIAL RESEARCH SUPPORTS RESEARCH THAT WILL LEAD TO GREATER UNDERSTANDING OF THE SOCIAL, CULTURAL, ECONOMIC AND PSYCHOLOGICAL FACTORS THAT AFFECT BOTH THE PROCESS OF GROWING OLD AND THE PLACE OF OLDER PEOPLE IN SOCIETY. THE DIVISION OF NEUROSCIENCE FOSTERS RESEARCH CONCERNED WITH THE AGE-RELATED CHANGES IN THE NERVOUS SYSTEM AS WELL AS THE RELATED SENSORY, PERCEPTUAL, AND COGNITIVE PROCESSES ASSOCIATED WITH AGING AND HAS A SPECIAL EMPHASIS ON ALZHEIMER'S DISEASE. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM: TO EXPAND AND IMPROVE THE SBIR PROGRAM, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, TO INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM: TO STIMULATE AND FOSTER SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO FOSTER TECHNOLOGY TRANSFER BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION.

93.866 - Aging Research

National Institute on Aging (NIA) [HHS - NIH]

Winston Salem, North Carolina 27157 United States

Single Zip Code

NIA Multi-site Clinical Trial Implementation Grant (R01 Clinical Trial Required) (PAR-19-302)

Amendment Since initial award the total obligations have increased 347% from $5,944,011 to $26,596,811.